The Role of c in cGMP

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's quality standards.

 

  • Design, monitoring, and control of manufacturing processes and facilities
  • Maintenance, calibration and validation of equipment
  • Role of qualified person and quality Indicators in GMP
  • Reliability and reproducibility of processes
  • Quality management systems

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